Cardiovascular

KRA · Catheter, Continuous Flush

Cardiovascular · 21 CFR 870.1210 · Class 2

Overview

Product CodeKRA
Device NameCatheter, Continuous Flush
Regulation21 CFR 870.1210
Device ClassClass 2
Review PanelCardiovascular
3rd-Party ReviewableYes

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Classification Rationale

Class II (performance standards).

Cleared Devices (173)

RecordDevice NameApplicantDecision DateDecision
K250794InVera Infusion DeviceInvera MedicalMar 12, 2026SESE
K243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedJul 30, 2025SESE
K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCNov 29, 2023SESE
K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.Jul 5, 2023SESE
K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.Jun 20, 2023SESE
K230957TriSalus TriNav® LV Infusion SystemTrisalus Life SciencesMay 2, 2023SESE
K223139Wallaby 017 Micro CatheterWallaby MedicalApr 25, 2023SESE
K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration CanisterArgon Medical Devices, Inc.Apr 10, 2023SESE
K230636Maestro MicrocatheterMerit Medical System, Inc.Mar 30, 2023SESE
K222679Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd.Nov 7, 2022SESE
K213435MAGIC Flow-Dependent MicrocatheterBalt USA, LLCJul 19, 2022SESE
K213442Extroducer Infusion Catheter SystemSmartWise Sweden ABJun 10, 2022SESE
K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARLApr 12, 2022SESE
K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd.Apr 11, 2022SESE
K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.Jan 7, 2022SESE
K210838PROWLER SELECT PLUS; PROWLER EXMedos International SARLAug 25, 2021SESE
K210339Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.Aug 2, 2021SESE
K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.Jul 16, 2021SESE
K210808Instylla Microcatheter 1.2Instylla, Inc.Apr 15, 2021SESE
K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 NeurovascularFeb 16, 2021SESE
K202366MAGIC Infusion CatheterBalt USA, LLCJan 29, 2021SESE
K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 NeurovascularSep 14, 2020SESE
K193082Fountain ValveTip Infusion CatheterMerit Medical Systems, Inc.Aug 7, 2020SESE
K201907ClariVein ICMerit Medical Systems, Inc.Aug 6, 2020SESE
K201792TRUSELECT MicrocatheterBoston Scientific CorporationJul 28, 2020SESE
K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.Jun 25, 2020SESE
K200744Instylla MicrocatheterInstylla, Inc.Apr 21, 2020SESE
K191305Hereaeus Poseidon MicrocatheterHeraeus Medical Components, LLCDec 19, 2019SESE
K193107TriSalus Infusion SystemTrisalus Life SciencesDec 3, 2019SESE
K191731Instylla MicrocatheterInstylla, Inc.Aug 13, 2019SESE
K182071Multi-Sideport Catheter Infusion SetCook IncorporatedApr 25, 2019SESE
K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLCNov 8, 2018SESE
K180275VAMP Optima closed blood sampling systemEdwards Lifesciences, LLCOct 24, 2018SESE
K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLCApr 5, 2018SESE
K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd.Jan 11, 2018SESE
K170931CXI TriForce Peripheral Crossing SetCook IncorporatedNov 13, 2017SESE
K172081Maestro MicrocatheterMerit Medical Systems, Inc.Aug 4, 2017SESE
K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific CorporationMay 16, 2017SESE
K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.Jan 27, 2017SESE
K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLCNov 28, 2016SESE
K160884CXI Support CatheterCook IncorporatedNov 22, 2016SESE
K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.Nov 4, 2016SESE
K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.Aug 18, 2016SESE
K161801CrossCath Support CatheterCook IncorporatedJul 29, 2016SESE
K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.Apr 15, 2016SESE
K152625MMS Guide CatheterMicro Medical Solutions, Inc.Mar 9, 2016SESE
K153502ClariVein ICVascular Insights, LLCJan 6, 2016SESE
K142259Direxion Torqueable MicrocatheterBoston Scientific CorpSep 10, 2014SESE
K140329RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KITBoston ScientificMay 15, 2014SESE
K140637PEREGRINE SYSTEM INFUSION CATHETERAblative Solutions, Inc.Mar 26, 2014SESE
K131772CANTATA(R) 2.9 MICROCATHETERCook, Inc.Feb 20, 2014SESE
K130569ND NABIL DIB INFUSION CATHETERTranslational Research InstituteNov 15, 2013SESE
K132947DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERSBoston Scientific CorpOct 18, 2013SESE
K123477VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc.Mar 19, 2013SESE
K122796CXI SUPPORT CATHETERCook, Inc.Oct 11, 2012SESE
K113289ORION MICRO CATHETERMicro Therapeutics, Inc.Aug 1, 2012SESE
K113773ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOLSt Jude MedicalJan 18, 2012SESE
K111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHSEv3, Inc.Sep 16, 2011SESE
K111263CXI TRIFORCECook IncorporatedJul 25, 2011SESE
K101450CANTATA MICROCATHETERCook, Inc.Dec 30, 2010SESE
K100892RENEGADE HI-FLO FATHOM KIT MODEL M001182XXXBoston Scientific CorpApr 12, 2010SESE
K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAEv3, Inc.Dec 9, 2009SESE
K093052CROSSCATH SUPPORT CATHTERCook, Inc.Dec 8, 2009SESE
K091559MARKSMANN CATHETERChestnut Medical Technologies, Inc.Sep 18, 2009SESE
K081147ISOFLOW INFUSION CATHETERVascular Designs, Inc.May 29, 2009SESE
K090870ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORYMicro Therapeutics, Inc.May 1, 2009SESE
K082613MERIT MICROCATHETERMerit Medical Systems, Inc.Dec 30, 2008SESE
K082163FLOWMEDICA BENEPHIT INFUSION SYSTEMSFlowmedica, Inc.Oct 29, 2008SESE
K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETERTerumo Medical Corp.Sep 26, 2008SESE
K080737MIRAFLEX HIGH FLOW MICROCATHETERCook, Inc.Aug 8, 2008SESE
K053310VASCON ROAMER MICROCATHETERVascon, LLCJul 3, 2008SESE
K073166ENDOWAVE INFUSION SYSTEMEkos Corp.Apr 22, 2008SESU
K071468CLARIVEIN CATHETERVascular Insights, LLCMar 20, 2008SESE
K073400VARICATH PERIPHERAL INFUSION CATHETERVeinrx, Inc.Dec 20, 2007SESE
K072724CXI SUPPORT CATHETERCook, Inc.Nov 9, 2007SESE
K070979PULL TAB SQUEEZE FLUSHIcu Medical, Inc.Sep 19, 2007SESE
K070384ARGON CONTINUOUS FLUSH DEVICEArgon Medical Devices, Inc.Mar 29, 2007SESE
K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETERCordis Neurovascular, Inc.Mar 14, 2007SESE
K062752MERCATOR MICROSYRINGE II INFUSION CATHETERMercator Medsystems, Inc.Dec 7, 2006SESE
K060224MODIFICATION TO MIRA-FLEX 18 MICROCATHETERCook IncorporatedMar 6, 2006SESE
K051990ECHELON MICRO CATHETERMicro Therapeutics, Inc.Jan 4, 2006SESE
K052841MIRA-FLEX 18 MICROCATHETERCook, Inc.Dec 8, 2005SESE
K052738INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044Veinrx, Inc.Dec 6, 2005SESE
K043538HYPERTRANSIT INFUSION CATHETERCordis Neurovascular, Inc.Apr 18, 2005SESE
K050630PIVOT STEERABLE MICROCATHETERBoston Scientific - Precision VascularMar 22, 2005SESE
K050205BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATHFlowmedica, Inc.Mar 4, 2005SESE
K042187ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90Micro Therapeutics, Inc.Sep 2, 2004SESE
K033913PROGREATTerumo Medical Corp.Mar 11, 2004SESE
K040139ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETEREndobionics, Inc.Feb 18, 2004SESE
K034036MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055Micro Therapeutics, Inc.Feb 13, 2004SESE
K033726PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETERPrecision VascularJan 16, 2004SESE
K033569FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATHFlowmedica, Inc.Jan 13, 2004SESE
K032494PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETERPrecision Vascular Systems, Inc.Sep 5, 2003SESE
K031992ECHELON MICRO CATHETER, MODEL 105-5091Micro Therapeutics, Inc.Aug 7, 2003SESE
K030688ECHELON MICRO CATHETER, MODEL 105-5092-150Micro Therapeutics, Inc.Mar 28, 2003SESE
K024122NAUTICA MICRO CATHETER, MODEL 105-5094-153Micro Therapeutics, Inc.Mar 7, 2003SESE
K023351MAGIC INFUSION CATHETERAdvanced Interventional Technologies, LLCFeb 20, 2003SESE
K024118ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066Micro Therapeutics, Inc.Feb 3, 2003SESE
K021591PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPSCordis Neurovascular, Inc.May 22, 2002SESE
K020680PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPSCordis Neurovascular, Inc.Mar 27, 2002SESE
K020733PVS 1500 SDSPrecision Vascular Systems, Inc.Mar 21, 2002SESE
K011646NEUROEDGE INFUSION CATHETERNeuro Vasx, Inc.Aug 27, 2001SESE
K010004FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065Micro Therapeutics, Inc.Feb 13, 2001SESE
K003925PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPSCordis Neurovascular, Inc.Jan 8, 2001SESE
K002723REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MAMicro Therapeutics, Inc.Sep 28, 2000SESE
K994155EXCELSIOR 1018 MICROCATHETERBoston Scientific, TargetAug 3, 2000SESE
K001966REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BANDMicro Therapeutics, Inc.Jul 20, 2000SESE
K000177RENEGADE HI-FLO MICROCATHETERBoston Scientific CorpApr 7, 2000SESE
K993672REBAR MICRO CATHETER, MODELS 105-5080, 105-5086Micro Therapeutics, Inc.Jan 4, 2000SESE
K993266PROWLER PLUS INFUSION CATHETERCordis Neurovascular, Inc.Oct 28, 1999SESE
K9830031 MASS TRANSIT INFUSION CATHETER, 1 VARIOUSCordis Neurovascular, Inc.Sep 17, 1998SESE
K974473EASY RIDER MICRO CATHETERMicro Therapeutics, Inc.Jun 17, 1998SESE
K980104FLOW RIDER FLOW DIRECTED MICRO CATHETERMicro Therapeutics, Inc.Apr 10, 1998SESE
K971619MICROFUSE MEMBRANE INFUSION CATHETERE-Med Corp.Feb 27, 1998SESE
K974222CES MASSTRANSIT INFUSION CATHETERCordis Neurovascular, Inc.Feb 10, 1998SESE
K973645RENEGADE FIBER BRAIDED MICROCATHETERBoston Scientific CorpNov 19, 1997SESE
K972518TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETERCordis Neurovascular, Inc.Nov 4, 1997SESE
K971306FG INFUSION CATHETERCordis Neurovascular, Inc.Jul 14, 1997SESE
K9648682.9F CRAGG-MCNAMARA VALVED INFUSION CATHETERMicro Therapeutics, Inc.May 20, 1997SESE
K962129CONTINUOUS FLUSH DEVICEMerit Medical Systems, Inc.Apr 15, 1997SESE
K965189SPINNAKERTarget TherapeuticsMar 24, 1997SESE
K965181CES INFUSION CATHETERCordis Neurovascular, Inc.Mar 21, 1997SESE
K964154SEGUE INFUSION CATHETERInterventional Innovations Corp.Jan 14, 1997SESE
K963988INTRAVASCULAR INFUSION DEVICEBoston Scientific CorpDec 12, 1996SESE
K961668MICROFERRET CATHETERCook, Inc.Nov 4, 1996SESE
K955525FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70Interventional Innovations Corp.Aug 8, 1996SESE
K955534SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)International Innovations, Inc.Aug 1, 1996SESE
K961294SCIMED DISPATCH GOLD CORONARY CATHETERScimed Life Systems, Inc.Jul 3, 1996SESE
K961527MX703 AND MX730 CONTINUOUS FLUSH DEVICESMedex, Inc.Jun 6, 1996SESE
K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERMedi-Tech, Inc.May 15, 1996SESE
K953133SCIMED DISPATCH CORONARY INFUSION CATHETERScimed Life Systems, Inc.Feb 23, 1996SESE
K954020MICRO THERAPEUTICS SIDEHOLE INFUSION WIREMicro Therapeutics, Inc.Jan 2, 1996SESE
K954949TRANSIT INFUSION CATHETER WITH SIDEHOLESCordis Neurovascular, Inc.Dec 22, 1995SESE
K952874TRANSIT INFUSION CATHETERCordis Neurovascular, Inc.Aug 21, 1995SESE
K952872SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETERScimed Life Systems, Inc.Jul 27, 1995SESE
K945666EVOLUTION(TM) MICROCATHETERBoston Scientific CorpJun 21, 1995SESE
K951602PULSE*SPRAY INFUSION SYSTEMAngiodynamics, Div. E-Z-Em, Inc.Jun 14, 1995SESE
K945909NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETERNavarre Biomedical , Ltd.Jun 2, 1995SESE
K945904SCIMED(R) VENTURE(TM) II INFUSION CATHETERScimed Peripheral InterventionsMay 19, 1995SESE
K951502CVD BULLET INFUSION CATYHETERCardiovascular Dynamics, Inc.May 10, 1995SESE
K951503CVD BULLETT HI-FLO INFUSION CATHETERCardiovascular Dynamics, Inc.May 4, 1995SESE
K945593SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETERScimed Life Systems, Inc.Jan 13, 1995SESE
K935349LOCALMED INFUSION CATHETERLocalmed, Inc.Oct 18, 1994SESE
K931335SCIMED(R) VENTURE(TM) INFUSION CATHETERScimed Life Systems, Inc.Jul 27, 1994SESE
K932800CARDIMA TRACKER(R) INFUSION CATHETERCardima, Inc.Dec 21, 1993SESE
K932616SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETERScimed Life Systems, Inc.Dec 15, 1993SESE
K932188SAFESET RESERVOIRAbbott LaboratoriesOct 25, 1993SESE
K921247ZEPHYR INFUSION CATHETERTarget TherapeuticsJun 29, 1993SESE
K914751SELECTIVE INFUSION II CATHETERAdvanced Cardiovascular Systems, Inc.May 24, 1993SESE
K924661SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETERBaxter Healthcare CorpApr 8, 1993SESE
K923368MAGIC INFUSION CATHETERTarget TherapeuticsApr 7, 1993SESE
K914979EDM(R) INFUSION CATHETERPeripheral Systems GroupSep 16, 1992SESE
K905447E-Z-EM PULSED INFUSION SYSTEME-Z-Em, Inc.Apr 1, 1991SESE
K896819VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONBaxter Healthcare CorpJan 19, 1990SESE
K885281VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONBaxter Healthcare CorpMar 3, 1989SESE
K884946JEHLE CORONARY PERFUSION CATHETERSPilling Co.Feb 6, 1989SESE
K874242JEHLE CORONARY PERFUSION CATHETERSPilling Co.Dec 7, 1987SESE
K860570ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICEParke-Davis Co.Mar 31, 1986SESE
K832058ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.Parke-Davis Co.Sep 12, 1983SESE
K831730CONTINUOUS FLUSH DEVICEAmerican Pharmaseal Div. AhscJul 18, 1983SESE
K831637ACCU-FLUSHAccu-LineJun 30, 1983SESE
K812173FLUSHFLO IIBentley Laboratories, Inc.Aug 18, 1981SESE
K811410MEDI-TRACEGraphic Controls Corp.Jun 12, 1981SESE
K801829MEDI-TRACE DISP. FLUSHING DEV./MONITORGraphic Controls Corp.Aug 27, 1980SESE
K801173ANGIO-FLO MONITORING KITHospital Products Co.May 28, 1980SESE
K791890CONTINUOUS FLUSH DEVICE, CAT. #14-370Norton Performance Plastics Corp.Dec 13, 1979SESE
K792141CONTINUOUS FLUSH DEVICEPharmaseal Div., Baxter Healthcare Corp.Dec 5, 1979SESE
K791844CRITIFLO & CRITIFLO DOMEGould, Inc.Oct 2, 1979SESE
K790455MICROFLUSHMedex, Inc.Mar 23, 1979SESE
K790327ANGIO-FLODeseret Medical, Inc.Feb 26, 1979SESE
K780479DELTA-FLOWTri-Delta Intl.Nov 22, 1978SESE
K770432MICROFLUSHMedex, Inc.Mar 16, 1977SESE
K761273FLUSHFLO-MODEL CC1-6Bentley Laboratories, Inc.Jan 12, 1977SESE

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